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    Clinical Research Associate

    Novotech
    2+ years
    Not Disclosed
    Remote
    10 Dec. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Research Associate (CRAII - SCRA)
    Location: Hybrid (Flexible working hours)
    Company: Novotech

    About Us:
    Novotech is a leading Asia-Pacific biotech specialist Contract Research Organization (CRO) with over 3,700 clinical projects, including Phase I to Phase IV trials and bioequivalence studies. With offices across 11 geographies, Novotech serves biopharmaceutical clients conducting clinical trials globally. We are committed to the highest IT security and quality standards and have obtained ISO 27001 and ISO 9001 certifications.

    Scope of Role:
    The Clinical Research Associate (CRAII - SCRA) is responsible for ensuring the protection of trial participants' rights and well-being while ensuring that trial data is accurate, complete, and verifiable from source documents. The CRA serves as the primary contact between Investigational Sites, Novotech, and the Sponsor, managing site relationships and ensuring clinical trials comply with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

    Responsibilities:

    • Build and maintain relationships with Principal Investigators, study coordinators, and other site personnel to ensure smooth management of clinical trials.
    • Foster internal and external customer relationships, ensuring efficient project delivery within study timelines.
    • Collaborate with in-house CRAs and Regulatory Start-Up Associates to prepare site essential documents and support ethics and regulatory submission processes.
    • Ensure participant recruitment according to site targets, preparing and updating site-specific recruitment plans.
    • Monitor investigational sites across all phases of clinical trials (e.g., Site Selection, Initiation, Monitoring, Close Out, unblinded pharmacy visits) either onsite or remotely.
    • Ensure all activities comply with ICH GCP and local regulations.
    • Provide support for the ethics and regulatory submission and approval processes.
    • Drive site recruitment and engagement initiatives to meet recruitment targets.

    Minimum Qualifications & Experience:

    • Graduate in clinical or life sciences-related fields (or relevant qualifications in allied professions).
    • CRA II: Minimum 6 months of independent CRA monitoring experience.
    • CRA III: 2+ years of independent CRA monitoring experience.
    • SCRA: 3+ years of independent CRA monitoring experience.
    • Must have unrestricted working rights in New Zealand.

    What We Offer:

    • Hybrid working arrangements with full flexibility in working hours.
    • A supportive, inclusive work environment.
    • Paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development opportunities.
    • We are an equal opportunity employer and support a diverse and inclusive workforce, welcoming individuals from all backgrounds, including those who identify as LGBTIQ+, have disabilities, or have caring responsibilities.

    Why Novotech:
    Novotech offers a workplace committed to gender equality, respect, and inclusivity. We are passionate about working in clinical research and biotechnology, providing career growth, flexibility, and work-life balance.

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